Technical Documentation for the Medical Device Regulation (MDR) - International

Niveau Spécialiste Durée 1 journée de formation

Disponible pour réserver: Salle de classe virtuelle 1080€ + TVA View dates and book now

A required part of conformity assessment and CE Marking is the need for technical documentation which includes the collation of supporting information about your medical device.

Technical documentation is maintained throughout the product lifecycle. Learn how to assemble this and other types of required information so you can CE Mark your device in Europe.

Prerequisites

You should have a basic understanding of European Medical Device Regulation (MDR).

Pedagogical objectives

Ensure auditable technical documentation meets regulatory requirements and demonstrates product safety and performance
Reduce delays to product certification by providing complete and compliant documentation
Reduce costs by reducing audit questions and nonconformities, thereby streamlining the certification process

QA/Regulatory personnel involved in compiling technical documentation; product design personnel and those in research and development for medical devices intended for the European market.
Upon completion of this training, you will be able to:
- Confirm the technical documentation requirements as specified in the MDR and relevant guidance documentation
- Interpret the MDR in relation to the technical documentation requirements
- Define the process enabling the creation and maintenance of compliant technical documentation
- Grasp how standards and guidance can be used to improve your technical documentation
- Recognize what is expected by Notified Bodies for technical documentation during reviews and be better prepared
- Recognize the documentation requirements during the product lifecycle and the post-market updates needed
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
Course materials including :
- Introduction to the training, detailed programme and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
This guide will give you all the necessary information.
Download our training guide: Technical Documentation for the MDR
* These training modules are eligible to the subsidizing by the public institutions in France (OPCO).

**Each delegate receives a training convention after enrollment.

***Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrollment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

****Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40.

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